FDA Orange Book · active-ingredient family
Fosaprepitant dimeglumine
Fosaprepitant dimeglumine is approved as 3 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:FOCINVEZ · NDA 216686
3
Brand (NDA)
18
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FOCINVEZRLD | STERISCIENCE | NDA 216686 | — | Aug 22, 2023 | |
| EMENDRLD×2 | MERCK AND CO INC | NDA 022023 | — | Jan 25, 2008 | |
| FOSAPREPITANT DIMEGLUMINE | TEVA PHARMS USA | NDA 210064 | — | Sep 05, 2019 |
Generic (ANDA) products (18)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FOSAPREPITANT DIMEGLUMINE | PIRAMAL CRITICAL | ANDA 214683 | — | May 16, 2023 | |
| FOSAPREPITANT DIMEGLUMINE | PRAXGEN | ANDA 213199 | — | Oct 04, 2021 | |
| FOSAPREPITANT DIMEGLUMINE | ASPIRO | ANDA 214616 | AP | Jul 29, 2021 | |
| FOSAPREPITANT DIMEGLUMINE | CHIA TAI TIANQING | ANDA 212143 | AP | Mar 03, 2021 | |
| FOSAPREPITANT DIMEGLUMINE | EUGIA PHARMA | ANDA 210625 | AP | Jan 12, 2021 | |
| FOSAPREPITANT DIMEGLUMINE | DR REDDYS | ANDA 211160 | AP | Dec 09, 2020 | |
| FOSAPREPITANT DIMEGLUMINE | CAPLIN | ANDA 203939 | — | Dec 08, 2020 | |
| FOSAPREPITANT DIMEGLUMINE | QILU PHARM HAINAN | ANDA 213106 | AP | Sep 08, 2020 | |
| FOSAPREPITANT DIMEGLUMINE | ACCORD HLTHCARE | ANDA 204025 | — | Aug 26, 2020 | |
| FOSAPREPITANT DIMEGLUMINE | NAVINTA LLC | ANDA 212957 | — | Aug 20, 2020 | |
| FOSAPREPITANT DIMEGLUMINE | APOTEX | ANDA 205020 | — | Sep 05, 2019 | |
| FOSAPREPITANT DIMEGLUMINE | BAXTER HLTHCARE CORP | ANDA 211860 | — | Sep 05, 2019 | |
| FOSAPREPITANT DIMEGLUMINE | BE PHARMS | ANDA 212309 | AP | Sep 05, 2019 | |
| FOSAPREPITANT DIMEGLUMINE | GENEYORK PHARMS | ANDA 211624 | — | Sep 05, 2019 | |
| FOSAPREPITANT DIMEGLUMINE | LUPIN | ANDA 210689 | — | Sep 05, 2019 | |
| FOSAPREPITANT DIMEGLUMINE | MSN | ANDA 209965 | AP | Sep 05, 2019 | |
| FOSAPREPITANT DIMEGLUMINE×2 | MYLAN LABS LTD | ANDA 204015 | — | Sep 05, 2019 | |
| FOSAPREPITANT DIMEGLUMINE | FRESENIUS KABI USA | ANDA 206197 | AP | Jun 09, 2016 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12042504 | Jan 11, 2039 | in 12 yr 9 mo | Product |
| 11065265 | Jan 11, 2039 | in 12 yr 9 mo | Product |
Fosaprepitant dimeglumine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
